BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BUNNY ELECTRODE/STEALTH ELECTRODE PRE WIRED EEG

    K Number: K911529 · Decision Nov 9, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    328
    Applicant Total
    5
    Review Days
    585

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    Basic Information

    Device Name
    BUNNY ELECTRODE/STEALTH ELECTRODE PRE WIRED EEG
    K Number
    K911529
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Lead-Lok, Inc.
    Date Received
    April 4, 1991
    Decision Date
    November 9, 1992
    Product Code
    DRX
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DRX Electrode, Electrocardiograph

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